NCT02035059

Predictability of Gestational Diabetes Mellitus in First and Second Trimester

Predictability of Gestational Diabetes Mellitus in First and Second Trimester, Using Novel Biomarkers, and the Development of New Biomarkers by Quantitative Proteomic Analysis

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 820 (actual)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The objective of the study is, if an early oral glucose tolerance test combined with maternal history, condition and multiple biomarker analysis can be used to detect gestational diabetes mellitus in the first trimester (12-14 weeks of gestation).

Detailed description

It is the investigators' aim to prospectively examine an extended form of the current 1st trimester screening test for the detection of foetal aneuploidy, in order to ascertain whether this can also be used for the detection of patients at-risk for gestational diabetes mellitus. For this purpose the investigators will include a combination of new markers in a multiplex bio-array manner in conjunction with an early oral glucose tolerance test. A nested case-control proteomic analysis will be performed in a retrospective manner at the completion of this study in order to develop more specific biomarker panels. The primary outcome will be development of gestational diabetes mellitus in the second or third trimester. The secondary endpoints are the delivery outcome, neonatal morbidity, neonatal mortality, maternal morbidity and costs.

Conditions

• Pregnancy
• Gestational Diabetes Mellitus

Timeline

• Start date: 2014-05-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2014-01-14
• Last updated: 2019-04-26

Locations

1 site across 1 country: Switzerland